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Accelerating
Clinical Trials
Worldwide

NexGen ClinOps Consulting delivers over 20 years of global experience and expertise in clinical research. Director-level consulting for biopharma, biotech, and CROs. Leverage over 12 years of global clinical program and project management, service provider oversight and regulatory success to optimize your trials.

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Years of industry expertise
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Trials managed globally
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Countries of operations
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Continents active
Core capabilities

Built for every
phase of your trial

NexGen ClinOps Consulting offers hands-on expertise across every phase of clinical trial execution, from start-up to closeout — including targeted SWAT and Rescue support for studies in distress.

Core Service

Project Management Excellence

Clinical development planning and execution. Budget development, forecasting, tracking, and risk mitigation. Timeline management and milestone delivery.

Years of global PM experience
Oversight

Full Clinical Operations Oversight

End-to-end study lifecycle management (Phases I–IV, FIH, pediatric, vaccine trials). Day-to-day operational leadership and team coordination. Study design input and protocol review support.

Phases I–IV · FIH · Pediatric · Vaccines
Start-Up

Regulatory & Study Start-Up Support

Regulatory submission, planning and document review. Country/site feasibility, selection, and activation. Global launch support (NA & LATAM, EMEA, APAC, CEE, and Africa).

NA · LATAM · EMEA · APAC · CEE · Africa
Monitoring

Monitoring Strategy & Execution

Monitoring · Data Flow · Service Providers, plans, documents and oversight. Monitoring and data flow oversight; query resolution support. Service providers alignment on monitoring strategy and reporting.

Monitoring · Data Flow · Service Providers
Medical

Medical & Scientific Support

Protocol and Protocol Amendments development support. Safety oversight collaboration and clinical data review. Deviation tracking, and trending analysis for operational oversight and improvements.

Protocol · Safety · Clinical Data Review
Quality

Audit/Inspection Readiness & GCP Compliance

Sponsor and site audit/inspection readiness; TMF management. SOP gap assessments; CAPA development & oversight. Continuous quality control & risk management.

TMF · SOP · CAPA · Continuous QC
WHY NEXGEN CLINOPS CONSULTING

Why NexGen ClinOps Consulting

20+ Years of Global Hands-On ClinOps Experience

From CRA to Director-level leadership — we bring deep operational insight across every phase of clinical trials. We bring expert-level leadership and full-lifecycle expertise across global clinical trials, from FIH to Phase IV.

Strategic Execution, Not Just Oversight

We don’t just run the study — we align clinical operations with strategic goals, ensuring compliance, quality, and delivery. We align operational delivery with your program’s bigger picture — driving timelines, compliance, and trial success.

SWAT & Rescue Support

Struggling study? We specialize in rapid-response interventions for stalled or at-risk clinical trials. Our SWAT-style support rapidly identifies root causes and gets trials back on track.

Therapeutic Breadth & Global Depth

Deep experience across cell therapy, oncology, gastroenterology, autoimmune disorders, cardiology, respiratory, endocrinology, vaccines, infectious diseases, and more — spanning global regions and emerging markets.

Flexible, Sponsor-Centric Solutions

We adapt to your trial’s needs — whether you need full oversight, temporary fill-in, a specialized operations partner, or anything in between.

CRO & Service Provider Oversight

We act as your eyes and ears — ensuring CROs and service providers deliver on expectations with proactive communication, quality tracking, and accountability at every step.

About the Founder

Petro Savchenko, MD
Founder & ClinOps Director

Dr. Petro Savchenko is a Clinical Operations & Project Management Expert with over 20 years of Global Clinical Research Experience. As a medical doctor with deep clinical operational expertise, Petro helps biopharma and CRO clients execute complex Phase I–IV clinical trials.

He led clinical programs in Oncology & Immuno-Oncology (CAR-T, LBCL, FL, CD70, etc.), Gastroenterology (Crohn's, UC, IBD), Cardiology, Endocrinology, Rheumatology, Psychiatry, Neurology, Infectious Diseases, and more.

  • Full project management: budgets, resources, timelines, risk management
  • CRO & service provider oversight
  • GCP compliance & audit/inspection readiness
  • TMF management
  • Data-driven medical and operational insights
  • Hands-on leadership for global, multi-country programs
Petro Savchenko, MD
Petro Savchenko, MD
Founder & ClinOps Director — 20+ years of global clinical research experience
Real results

Case Studies

Proven outcomes from complex clinical programs around the world.

FIH Trial Rescue
Case Study

First-In-Human Trial Rescue

Client: Emerging Biotech, US-based

Challenge

FIH study was delayed due to vendor misalignment and protocol deviation risks.

Our Solution
  • Stepped in as interim Clinical Operations Lead.
  • Rebuilt the study timeline, re-trained site staff, and aligned CRO.
  • Established a robust risk-based monitoring (RBM) plan.
Outcome
  • Study restarted in 3 weeks.
  • First patient dosed ahead of the revised schedule.
  • No major findings during FDA pre-IND inspection.
Phase II Stabilization
Case Study

Phase II Program Stabilization

Client: Mid-size US Sponsor

Challenge

Phase II oncology study across 7 countries was under-enrolling and facing frequent protocol amendments.

Our Solution
  • Conducted feasibility reassessment and added 5 high-performing sites.
  • Streamlined CRO communication and handled amendment coordination.
  • Implemented weekly data and enrollment analytics dashboards.
Outcome
  • Enrollment rate increased by 70%.
  • Protocol amendment finalized without delays.
  • Study locked on time and within budget.
Phase III IBD
Case Study

Phase III Pivotal Study Oversight

Client: Large Global Biopharma

Challenge

Needed high-level operational oversight for a pivotal Phase III IBD trial in 30+ countries.

Our Solution
  • Provided strategic program oversight and service provider governance.
  • Coordinated with global medical team on safety reporting and IDMC.
  • Led global site activation and maintained regulatory compliance.
Outcome
  • Study enrolled 2,600 patients within target window.
  • NDA submission accepted by FDA with zero data integrity concerns.
  • Drug has been successfully marketed.
Knowledge hub

Industry Insights

Clinical operations insights from NexGen ClinOps Consulting

Operational resilience in clinical trialsClinOps Strategy

The Proactive Shift: Building Operational Resilience in Clinical Trials

Success is no longer about just reaching a goal — it's about predicting the obstacles on the journey. A resilient trial is built on data-informed site selection, flexible protocol design, and real-time predictive analytics.

Read on LinkedIn →
Risk-based quality management in clinical trialsRBQM

Risk-Based Quality Management — From Theory to Practice

Too many teams still treat RBQM as a regulatory checkbox. Real RBQM identifies critical-to-quality factors early, builds KRIs that trigger action, and embeds risk review into governance — changing decisions, not just dashboards.

Read on LinkedIn →
Clinical trial site engagementSite Engagement

Why Site Engagement Makes or Breaks a Trial

You can have the best protocol, the strongest CRO, and the most innovative drug — but if sites aren't engaged, timelines slip and data suffers. Engaged sites mean faster enrollment, better retention, and higher quality data.

Read on LinkedIn →
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Get in touch

Let's collaborate!

Looking for Director-level Clinical Operations expertise to support your clinical trial? Let’s discuss how NexGen ClinOps Consulting can help.

  • info@nexgenclinops.com

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